drugset / Trial / NCT06464367

Mechanistic Studies of Psilocybin in Headache Disorders

NCT06464367

Phase 0 Recruiting 50 enrolled Yale University The Wallace Foundation · collab
RandomizedParallel-groupQuadruple-blindOther

Summary

In previous clinical trial work, the investigators observed lasting reductions in headache burden after limited dosing of psilocybin. This purpose of this study is to examine potential sources for this observed effect. This study will measure brain resting state functional connectivity (fMRI), central synaptic density (SV2A PET), peripheral markers of inflammation, circadian rhythm (actigraphy), and sleep (sleep EEG) in both migraine and healthy control participants before and one week after the administration of psilocybin or an active control agent.

Timeline

Start
2025-05-19
Primary completion
2027-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Psilocybin Other / unclassified 10 mg Oral

Indications